RegulationBreakthrough Therapy (US), Orphan Drug (US), Conditional marketing approval (CN), Priority Review (US), Accelerated Approval (US), Orphan Drug (EU)

Structure

Molecular FormulaC26H23N7O2

InChIKeyWDENQIQQYWYTPO-IBGZPJMESA-N

CAS Registry1420477-60-6

178

Clinical Trials associated with Acalabrutinib

NCT06520098 / Not yet recruitingPhase 2IIT

Benefit of Venetoclax Addition ("Benefit VA") in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

People who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are often treated with ibrutinib, acalabrutinib, or zanubrutinib. These are pills that are taken by mouth. This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax.
The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetoclax to the current treatment (BTKi), for one year. After one year, both pills in this arm of treatment would be stopped and the participants will be closely monitored.

Start Date01 Jan 2025

Sponsor / Collaborator

VA Office of Research and Development

NCT06441097 / Not yet recruitingPhase 2IIT

A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Start Date31 Dec 2024

Sponsor / Collaborator

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

NCT06054776 / RecruitingPhase 2IIT

A Phase 2 Study of Glofitamab With Acalabrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

This phase II trial studies the side effects of acalabrutinib, obinutuzumab, and glofitamab and how well they work together for treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Glofitamab is a class of medications called bispecific antibodies. Bispecific antibodies are designed to simultaneously bind to T cells and cancer cell antigens, leading to T-cell activation, proliferation, and cancer cell death. Giving acalabrutinib, obinutuzumab, and glofitamab together may be a safe and effective treatment for patients with relapsed or refractory mantle cell lymphoma.

Start Date10 Dec 2024

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Acalabrutinib

100 Translational Medicine associated with Acalabrutinib

100 Patents (Medical) associated with Acalabrutinib

477

Literatures (Medical) associated with Acalabrutinib

01 Dec 2024·Journal of pharmacy practice

CNS Aspergillosis and Cryptococcosis with Cytomegalovirus Pneumonia in a Patient with Chronic Lymphocytic Leukemia Treated with Acalabrutinib

Article

Author: Siegrist, Emily A. ; Thacker, Erica ; Fallin, Taylor ; Shibib, Dena ; Summers, Katherine ; Sassine, Joseph ; Sahra, Syeda ; White, Bryan P.

Bruton’s tyrosine kinase inhibitors (BTKis) are the preferred treatment for chronic lymphocytic leukemia (CLL). Despite their therapeutic benefits, these targeted agents have been associated with an increased risk of invasive infections. We describe a 68-year-old male who developed multiple bacterial, fungal and viral infections while on treatment with acalabrutinib. To our knowledge, this is the first reported case of concomitant CNS infections with Cryptococcus neoformans and Aspergillus fumigatus, along with cytomegalovirus (CMV) and herpes simplex virus type 1 (HSV-1) pneumonia while on acalabrutinib. This case adds to the scarce literature of fungal and bacterial infections associated with acalabrutinib, raising the suspicion that infection risk is a medication class effect for BTKis.

01 Oct 2024·JCO Oncology Practice

Current Approaches and Novel Agents in the Treatment of Chronic Lymphocytic Leukemia

Review

Author: Cheson, Bruce D. ; Sharman, Jeff P.

The treatment of CLL has evolved from traditional chemoimmunotherapy (CIT) to an increasing number of targeted and biologic approaches. Randomized trials have demonstrated superiority of covalent bruton tyrosine kinase inhibitors (cBTKis) over CIT, and second-generation compounds such as acalabrutinib and zanubrutinib appear to have a more favorable efficacy/safety profile than ibrutinib. The noncovalent BTKi, pirtobrutinib, has shown impressive activity after failure of the cBTKis and is quite tolerable. The Bcl-2 inhibitor venetoclax plus a CD20, generally obinutuzumab, provides a high level of efficacy as initial treatment or after failure on a cBTKi, with many patients achieving a state of undetectable minimal residual disease. Promising novel approaches include BTK degraders, bispecific antibodies, and chimeric antigen receptor T-cell (CAR-T)-cell therapy. What is clear is that CIT is archaic, and current and future targeted approaches will continue to improve the outcome for patients with chronic lymphocytic leukemia.

01 Oct 2024·Clinical Lymphoma Myeloma & Leukemia

Real-World Treatment Patterns, Survival, and Economic Burden Among Elderly MCL Patients Previously Treated With cBTKis

Article

Author: Kamal-Bahl, Sachin ; Squires, Patrick ; Raut, Monika ; Ryland, Katherine Elizabeth ; Huntington, Scott F ; Doshi, Jalpa ; Puckett, Justin

BACKGROUND:

While covalent Bruton's tyrosine kinase inhibitors (cBTKis) have become a standard of care treatment for relapsed/refractory mantle cell lymphoma (R/R MCL), response duration is limited and resistance to BTKi and/or adverse events develop in a subset of patients. However, little real-world evidence on post-cBTKi clinical and economic outcomes exists for these patients.

PATIENTS AND METHODS:

This retrospective study used 2010 to 2019 U.S. Medicare claims, to identify elderly (≥ 66 years) patients with newly-diagnosed MCL who received third-line (3L) treatment and had evidence of cBTKi use in a prior line of therapy. Outcomes were assessed ≥ 12-months post 3L-treatment initiation and included treatment patterns, all-cause and MCL-related HRU and costs, and overall survival.

RESULTS:

The final sample contained 230 elderly patients with R/R MCL receiving 3L treatment who had cBTKi use in a prior line of therapy (mean age 75.0, 21.7% age > 80 years; 67.4% male; 93.9% White). Common 3L treatments included chemotherapy (26.1%), lenalidomide (18.7%), and bortezomib (18.3%); 1-quarter (25.7%) of patients received a cBTKi (17.8% ibrutinib; 7.8% acalabrutinib). Overall survival was poor from 3L treatment initiation (median OS = 9.4 months; 1-years survival rate = 43.7%). Patients exhibited high rates of HRU (73.6% experienced hospitalization) and substantial costs ($145,726) in the 12-months after 3L initiation.

CONCLUSION:

A large unmet need exists in this patient subpopulation, highlighting the importance of ongoing development of novel therapeutics.

111

News (Medical) associated with Acalabrutinib

19 Sep 2024

·www.prnewswire.com

Mantle Cell Lymphoma Clinical Trial Pipeline Insights Featuring 20+ Companies | DelveInsight

Mantle cell lymphoma is a rare and aggressive type of non-Hodgkin lymphoma originating from B-cells in the "mantle zone" of the lymph nodes. The development of novel targeted therapies and immunotherapies, such as Bruton's tyrosine kinase (BTK) inhibitors, is improving treatment outcomes and driving market growth for Mantle cell lymphoma. LAS VEGAS, Sept. 19, 2024 /PRNewswire/ -- DelveInsight's ' Mantle Cell Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline mantle cell lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the mantle cell lymphoma pipeline domain. Key Takeaways from the Mantle Cell Lymphoma Pipeline Report DelveInsight's mantle cell lymphoma pipeline report depicts a robust space with 20+ active players working to develop 22+ pipeline therapies for mantle cell lymphoma treatment. Key mantle cell lymphoma companies such as AbbVie, Adicet Bio, InnoCare Pharma Inc., Guangzhou Lupeng Pharmaceutical Company LTD., BeiGene, Nurix, LegoChem Biosciences, Xynomic Pharmaceuticals, Merck & Co, Incyte Corporation, TG Therapeutics, Janssen/Pharmacyclics, Eternity Bioscience, Traws Pharm, Advenchen Laboratories, and others are evaluating new mantle cell lymphoma drugs to improve the treatment landscape. Promising mantle cell lymphoma pipeline therapies such as Venetoclax, ADI-001, Orelabrutinib, LP-168, BGB-11417, NX 2127, LCB 71, NX 5948, Abexinostat, Pembrolizumab, Parsaclisib, Umbralisib, Ibrutinib, Edralbrutinib, Narazaciclib, Lucitanib, and others are under different phases of mantle cell lymphoma clinical trials. In May 2024, AstraZeneca had announced positive interim results from the Phase III ECHO clinical trial, which evaluated Bruton's tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in combination with standard chemoimmunotherapy for treating mantle cell lymphoma (MCL). In March 2024, BeiGene, Ltd. announced the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) Annual Meeting. Additional highlights include preclinical characterization data for an investigational BTK degrader, BGB-16673, currently in clinical development for B-cell malignancies, including mantle cell lymphoma In October 2023, Ascentage Pharma announced that it has entered into a clinical collaboration with AstraZeneca Investment. The two companies will jointly conduct a registrational Phase III study of the Bcl-2 inhibitor, APG-2575 (lisaftoclax), in combination with AstraZeneca's Bruton's tyrosine kinase (BTK) inhibitor, CALQUENCE® (acalabrutinib), in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). In January 2023, the FDA granted an orphan drug designation to LP-284, a novel small-molecule, next-generation acylfulvene, for the treatment of mantle cell lymphoma (MCL), a rare and aggressive form of B-cell non-Hodgkin lymphoma (NHL), according to an announcement from Lantern Pharma. Request a sample and discover the recent advances in mantle cell lymphoma treatment drugs @ Mantle Cell Lymphoma Pipeline Report The mantle cell lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage mantle cell lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the mantle cell lymphoma clinical trial landscape. Mantle Cell Lymphoma Overview Mantle cell lymphoma (MCL) is a rare subtype of B-cell non-Hodgkin lymphomas (NHLs) characterized by the (11,14) translocation, leading to overexpression of the cyclin D1 (CCND1) gene. Its various morphological variants can make diagnosis challenging, though some cases are straightforward. Many individuals with MCL are asymptomatic in the early stages, but may later seek medical attention due to persistent, typically painless swelling of lymph nodes, especially in the neck and throat region (e.g., Waldeyer's ring). MCL is marked by a reciprocal chromosomal translocation t(11;14)(q13;q32), which places the cyclin D1 gene next to the immunoglobulin heavy chain gene, causing continuous cyclin D1 expression. This overexpression contributes to tumor cell proliferation through cell cycle dysregulation, chromosomal instability, and epigenetic changes. Rarely, MCL cases without this translocation may involve CCND2 or CCND3 translocations. Hypothetical molecular subtypes, based on the cell of origin, correlate with clinical phenotypes: classical or aggressive MCL arises from naive B cells lacking or having limited iGVH mutations and expressing SOX11, a neural transcription factor inhibiting terminal B cell differentiation. The indolent variant originates from antigen-experienced B cells with IGVH somatic hypermutations, typically SOX11-negative and genetically stable. Diagnosis of MCL involves detailed patient history, thorough clinical evaluation, and specialized tests, including biopsy of an affected lymph node or bone marrow. These tests confirm the NHL type and subtype, assess disease extent, and determine appropriate treatments. Treatment for MCL is multifaceted and tailored to each patient, often including chemotherapy, immunotherapy drugs like rituximab, targeted therapies such as ibrutinib, and stem cell transplants, particularly for aggressive disease or younger patients. Radiation therapy may target specific lymphoma areas. Participation in clinical trials can offer new treatment options. Treatment plans are developed collaboratively by healthcare professionals and patients, considering disease stage, overall health, and personal preferences. Regular monitoring and follow-up care are essential to track treatment response and manage side effects effectively. Find out more about mantle cell lymphoma treatment drugs @ Drugs for Mantle Cell Lymphoma Treatment A snapshot of the Mantle Cell Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging mantle cell lymphoma pipeline therapies @ Mantle Cell Lymphoma Clinical Trials Mantle Cell Lymphoma Therapeutics Assessment The mantle cell lymphoma pipeline report proffers an integral view of the mantle cell lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Mantle Cell Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Apoptosis stimulants, Proto-oncogene protein c-bcl-2 inhibitors, Proteasome inhibitors, Immunologic cytotoxicity, T lymphocyte replacements, Agammaglobulinemia tyrosine kinase inhibitors Key Mantle Cell Lymphoma Companies: AbbVie, Adicet Bio, InnoCare Pharma Inc., Guangzhou Lupeng Pharmaceutical Company LTD., BeiGene, Nurix, LegoChem Biosciences, Xynomic Pharmaceuticals, Merck & Co, Incyte Corporation, TG Therapeutics, Janssen/Pharmacyclics, Eternity Bioscience, Traws Pharm, Advenchen Laboratories, and others Key Mantle Cell Lymphoma Pipeline Therapies: Venetoclax, ADI-001, Orelabrutinib, LP-168, BGB-11417, NX 2127, LCB 71, NX 5948, Abexinostat, Pembrolizumab, Parsaclisib, Umbralisib, Ibrutinib, Edralbrutinib, Narazaciclib, Lucitanib, and others Dive deep into rich insights for new drugs for mantle cell lymphoma treatment, visit @ Mantle Cell Lymphoma Drugs Table of Contents For further information on the mantle cell lymphoma pipeline therapeutics, reach out @ Mantle Cell Lymphoma Treatment Drugs Related Reports B-Cell Lymphoma Epidemiology B-Cell Lymphoma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the B-cell lymphoma epidemiology trends. B-Cell Lymphoma Market B-Cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key B-cell lymphoma companies, including Vincerx Pharma, Ubix Therapeutics, Biomea Fusion Inc, Shanghai Hengrui Pharmaceutical, BeiGene, Hanmi Pharmaceutical, among others. Diffuse Large B-Cell Lymphoma Pipeline Diffuse Large B-Cell Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key DLBCL companies, including Genmab, Roche, Acerta Pharma, Autolus, Xynomic Pharmaceuticals, Genentech, Celgene, AbbVie, Mabion, among others. Diffuse Large B-Cell Lymphoma Market Diffuse Large B-Cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key B-cell lymphoma companies, including AbbVie, Genmab, Merck, Roche, Xencor and Janssen, Denovo Biopharma, Calithera Biosciences, IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3ImmunotherapyOrphan Drug

30 Jul 2024

·pmlive.com

AstraZeneca’s Calquence combination shows promise in chronic lymphocytic leukaemia

AstraZeneca (AZ) has shared positive results from a late-stage study of its Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in chronic lymphocytic leukaemia (CLL). The phase 3 AMPLIFY trial has been evaluating the drug plus venetoclax, with and without obinutuzumab, compared to standard-of-care chemoimmunotherapy in adults with previously untreated CLL. According to an interim analysis, the Calquence combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemoimmunotherapy. A trend was also observed in favour of the combination for the secondary endpoint of overall survival (OS), but this data was not mature at the time of the analysis and the trial will continue to further assess OS. CLL is the most prevalent type of leukaemia in adults globally, with approximately 4,000 new cases of the disease diagnosed every year in the UK alone. Despite being considered an incurable cancer, patients often live with the disease for many years and may remain on continuous treatment. Susan Galbraith, executive vice president, oncology research and development, AZ, said the results “demonstrate the potential of including a BTK inhibitor in a fixed-duration regimen”. Principal investigator Jennifer Brown, Dana-Farber Cancer Institute and Harvard Medical School, said: “This is an important advance in this setting as fixed-duration regimens allow those living with [CLL] to take breaks from their treatment, thereby decreasing the possibility of long-term adverse events and drug resistance and improving quality of life.” Calquence is already approved in Europe, the US and several other countries to treat certain cases of CLL. “If approved, Calquence would become the only second-generation BTK inhibitor available as both a treat-to-progression and fixed-duration treatment, providing more options for patients and their healthcare providers,” Galbraith said. AZ said the data will be presented at an upcoming medical meeting and shared with global regulatory authorities. Beyond CLL, Calquence also holds approvals to treat certain patients with small lymphocytic lymphoma and mantle cell lymphoma (MCL). The company shared positive results last month for the drug plus standard-of-care chemoimmunotherapy bendamustine and rituximab in adults with previously untreated MCL. The combination reduced the risk of disease progression or death by 27% compared to chemoimmunotherapy. Median PFS was 66.4 months for patients treated with the Calquence combination versus 49.6 months for those receiving chemoimmunotherapy.

Clinical ResultPhase 3ImmunotherapyDrug ApprovalBiosimilar

29 Jul 2024

·www.fiercepharma.com

AstraZeneca trumpets new Calquence combos in CLL. Can they change clinical practice?

In an announcement, AstraZeneca placed a focus on the fixed-duration design feature of the latest Calquence regimens in chronic lymphocytic leukemia. With a phase 3 trial win claimed by AstraZeneca, the heated BTK inhibitor race might see its first triplet regimen in chronic lymphocytic leukemia (CLL).Monday, AZ said its BTK drug Calquence, used in combination with venetoclax—both with or without Roche’s Gazyva—outperformed traditional chemoimmunotherapy at staving off tumor progression or death in patients with previously untreated CLL.The trial's positive top-line results come from an interim analysis of the phase 3 AMPLIFY trial. Previously, AZ anticipated a readout from the trial to come in the second half of 2025. An AZ spokesperson confirmed to Fierce Pharma that the doublet and the triplet regimens met their progression-free survival goals separately under the trial design.AZ said it will discuss the results with regulatory bodies. The two Calquence combos also showed a trend toward extending patients’ lives, although the overall survival data remained immature at the time of the analysis.It’s been nearly five years since the FDA’s approval for Calquence, either alone or in combination with Gazyva, in CLL, the largest indication for the BTK inhibitor class. Past first-line CLL approvals for BTK inhibitors, including for Calquence, were based on positive PFS data—rather than survival findings—as patients with the disease can live for a very long time.With the AMPLIFY trial win, the Calquence-venetoclax-Gazyva cocktail may become the first BTK-containing triplet treatment in CLL. In Monday’s announcement, AZ placed a focus on the regimen’s design feature that allows patients to stop treatment after a certain amount of time. AbbVie and Johnson & Johnson’s first-to-market BTK med, Imbruvica, also offers a fixed-duration combo with venetoclax in Europe and Canada thanks to results from the phase 3 GLOW study. “This is an important advance in this setting as fixed-duration regimens allow those living with this chronic disease to take breaks from their treatment, thereby decreasing the possibility of long-term adverse events and drug resistance and improving quality of life,” Jennifer Brown, M.D., Ph.D., from the Dana-Farber Cancer Institute and an investigator of AMPLIFY, said in a statement.“If approved, Calquence would become the only second-generation BTK inhibitor available as both a treat-to-progression and fixed-duration treatment, providing more options for patients and their healthcare providers," AstraZeneca's executive vice president of oncology R&D, Susan Galbraith, Ph.D., said in a statement.Still, whether these Calquence combos can become new treatment standards remains to be seen.Importantly, AMPLIFY’s comparator arm used chemoimmunotherapies such as the combination of bendamustine and rituximab, which are less common in the U.S. under current National Comprehensive Cancer Network (NCCN) guidelines for treatment.Calquence with or without Gazyva, BeiGene’s rival BTK drug Brukinsa and the venetoclax-Gazyva combo serve as the preferred first-line regimens in CLL without del(17p) or TP53 mutations, the same population enrolled in AMPLIFY, according to NCCN guidelines. Various therapies using Imbruvica constitute other recommended regimens.AZ does also have the phase 3 MAJIC trial, which is pitting finite treatment with Calquence-venetoclax against venetoclax-Gazyva in front-line CLL.Better safety profiles have made Calquence and Brukinsa the favored BTK drugs compared with Imbruvica. In Monday’s release, AZ pointed to low rates of cardiac toxicity observed with Calquence in the AMPLIFY trial. In the second quarter, Calquence’s sales grew 10% sequentially, reaching $790 million, as AZ touted the drug’s leadership in first-line CLL.Meanwhile, Calquence’s combination with bendamustine and rituximab recently showed a positive overall survival trend against the chemoimmunotherapy in previously untreated mantle cell lymphoma.In the key battleground of first-line CLL, BeiGene is pairing Brukinsa with the company’s own BCL2 inhibitor sonrotoclax in a phase 3 trial against the venetoclax-Gazyva combo. Sonrotoclax appears to be an improved version of venetoclax with better potency and safety.Without a combo nod, Brukinsa generated $489 million in the first quarter. But after an FDA nod in follicular lymphoma in March, the BeiGene drug boasts the broadest label within the BTK class in terms of disease types.

Phase 3ImmunotherapyClinical ResultDrug Approval

100 Deals associated with Acalabrutinib

External Link

KEGG	Wiki	ATC	Drug Bank
D10893	Acalabrutinib	L01XE51	DB11703

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Small Lymphocytic Lymphoma	US	AstraZeneca UK Ltd.	21 Nov 2019
Chronic Lymphocytic Leukemia	CA	AstraZeneca Canada, Inc.	02 Oct 2019
Mantle-Cell Lymphoma	US	AstraZeneca UK Ltd.	31 Oct 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Large B-cell lymphoma	Phase 3	DE	AstraZeneca PLC	07 Jun 2023
Diffuse Large B-Cell Lymphoma	Phase 3	US	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	CN	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	JP	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	AU	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	AT	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	BE	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	BR	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	CA	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	CZ	AstraZeneca PLC	08 Oct 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03788291 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	39	Acalabrutinib+Rituximab	bznrvfirph(lkgyoqfhng) = vrlgycjnuu ttoxvmxqwi (fkflyeghmh, uqrsjezjxh - inqhvgfxwn) View more	-	26 Sep 2024
NCT02717624 (Pubmed \| Blood Adv) Manual	Phase 1	Mantle-Cell Lymphoma	21	Acalabrutinib+venetoclax+rituximab	rkwbmqiunu(qozxgxoyzm) = apejnmebjs bljhmdssef (nvvdtisjdy ) View more	Positive	10 Sep 2024
NCT02477696 (ELEVATE-RR, Pubmed \| Blood)	Phase 3	Chronic Lymphocytic Leukemia BTK mutations \| TP53 mutations \| PLCG2 mutations	-	Acalabrutinib-treated patients	faxibbtzbu(cakuyhabeu) = jpudeurqnf mjffvczroc (qoqnvfyash ) View more	-	05 Sep 2024
				Ibrutinib-treated patients	faxibbtzbu(cakuyhabeu) = dibtfjpwfv mjffvczroc (qoqnvfyash ) View more
NCT02475681 \| NCT03336333 (Pubmed \| Blood Adv) Manual	Phase 3	Chronic Lymphocytic Leukemia First line del(17p)	-	Acalabrutinib plus obinutuzumab	-	Positive	11 Jun 2024
				Acalabrutinib monotherapy
NCT02972840 (ECHO, EHA2024) Manual	Phase 3	Mantle-Cell Lymphoma First line	598	Acalabrutinib + Bendamustine + Rituximab	ztdsaavkfz(cuqmcoabii) = qzprnytvme uaozwbtcku (bcxfshkcsb ) View more	Positive	03 Jun 2024
				Placebo + Bendamustine + Rituximab	ztdsaavkfz(cuqmcoabii) = bjkgtcsmiz uaozwbtcku (bcxfshkcsb ) View more
NCT04657094 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia \| Autoimmune Haemolytic Anaemias	4	Acalabrutinib	yhdmnuqeeb(oqymchhojt) = nhmxlpxwyt emquksbzcd (jzqviffahg, zwumnzmhdy - tmwdknvima) View more	-	29 May 2024
ASCEND (ASCO2024) Manual	Not Applicable	Chronic Lymphocytic Leukemia	-	Zanubrutinib (High-Risk With COVID-19 Adjustment)	iqhjyvmwms(kdygzldioc): 0.54 (95% CI, 0.32 - 0.92) View more	Positive	24 May 2024
				Acalabrutinib (High-Risk With COVID-19 Adjustment)
NCT04008706 (ASSURE, EHA2024) Manual	Phase 3	Chronic Lymphocytic Leukemia del(17p)/TP53m \| uIGHV	552	Acalabrutinib 100 mg	jujjvvbgys(gvtextzhka) = pddkjpkjma zsvfyorjaa (eibaekzurb ) View more	Positive	14 May 2024
NCT04722172 (EHA2024) Manual	Phase 2	Chronic Lymphocytic Leukemia First line TP53 deletion \| del13q \| tri12 ... View more	55	Acalabrutinib + obinutuzumab	xgrjanhgle(feeuctudef) = mjafbmoooq vmymsumwxr (ppbmowltaq ) View more	Positive	14 May 2024
				Acalabrutinib + obinutuzumab (del11q)	xgrjanhgle(feeuctudef) = aqrgclkzuu vmymsumwxr (ppbmowltaq )
NCT05557695 (EPIC, EHA2024) Manual	Not Applicable	Chronic Lymphocytic Leukemia First line ATM Mutation \| Gene \| del(17p13.1) \| ... View more	170	Acalabrutinib	elrtpdiziq(pyenzavfdk) = most common adverse events leading to discontinuations (≥1 AE could be reported per discontinuation) included cardiovascular, haematoma, and Richter transformation (n=2 each) cnodjzogzz (bivkcqkopd )	Positive	14 May 2024

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